The General Medical Counsel is set to publish their findings this week in the case of Doctors Wakefield, Walker-Smith and Murch. With that deadline there is a lot of discussion going on about the GMC hearings. I see a lot of comments about how this is some sort of referendum on the research, which isn’t really the case. So, I thought I would (again) post the list of charges.
Below is a short version. I say short because the full version is 93 pages long.
The goal of the GMC is *not* to determine the scientific quality of the research. Rather, it is to determine whether the three doctors acted ethically in their treatment of their patients and whether they acted ethically in preparing the research report. It is a “fit to practice” determination. I.e. the question asked is whether these gentlemen “fit to practice” medicine in the UK, not whether their research was accurate or of high quality.
The focus of the inquiry on the ethical treatement of the patients is why you will find the phase “Your conduct as set out above was contrary to the clinical interests of Child X” repeatedly in the GMC charges.
To make this point clear, here is a section of the GMC statements
The GMC does not regard its remit as extending to arbitrating between competing scientific theories generated in the course of medical research.
The GMC hearing is not about whether the team led by Dr. Wakefield questioned the safety of MMR. It is about whether they acted in an ethical manner. The accusations are quite serious in nature. I count about 30 instances of the phrase “contrary to the clinical interests” in the GMC charges. I personally find those charges to be the most serious. Well beyond any questions of professional misconduct involving the research paper.
At this point, these are still charges. Many are listed as “admitted and found proved”, but those are mostly statements of recorded facts such as what procedures were performed on specific children and when.
With that in mind, here is a short version of the GMC’s description of the Fitness to Practice Panel’s effort:
Dr Andrew WAKEFIELD
Professor John WALKER-SMITH
Professor Simon MURCHFitness to Practise Panel
Planned dates: 4 – 29 January 2010
This session is expected to last 20 days.Please note that the Panel is currently deliberating in private session until further notice.
The Fitness to Practise Panel will meet at Regent’s Place, 350 Euston Road, London NW1 3JN, to continue its inquiry into three new cases of conduct.
This case will be considered by a Fitness to Practise Panel applying the General Medical Council’s Preliminary Proceedings Committee and Professional Conduct Committee (Procedure) Rules 1988.
Dr Andrew WAKEFIELD
GMC Reference number: 2733564
Professor John WALKER-SMITH GMC Reference number: 1700583
Professor Simon MURCH
GMC Reference number: 2540201The GMC’s statutory purpose is to protect, promote and maintain the health and safety of the public by ensuring proper standards in the practice of medicine.
We investigate complaints about individual doctors in order to establish whether their fitness to practise is impaired and whether to remove or restrict a doctor’s registration.
The GMC does not regard its remit as extending to arbitrating between competing scientific theories generated in the course of medical research.
The following is a summary only of the allegations which will be made before the Panel at the forthcoming hearing.
The Panel will inquire into allegations of serious professional misconduct by Dr Wakefield, Professor Walker-Smith and Professor Murch, in relation to the conduct of a research study involving young children from 1996-98.
Dr Wakefield, Professor Walker-Smith and Professor Murch, were at the relevant times employed by the Royal Free Hospital School of Medicine with Honorary Clinical contracts at the Royal Free Hospital.
It is alleged that the three practitioners were named as Responsible Consultants on an application made to the Ethical Practices Committee of the Royal Free Hospital NHS Trust (“the ethics committee”) in 1996 to undertake a research study involving children who suffered from gastrointestinal symptoms and a rare behavioural condition called disintegrative disorder. The title of the study was “A new paediatric syndrome: enteritis and disintegrative disorder following measles/rubella vaccination”.
The Panel will inquire into allegations that the three practitioners undertook research during the period 1996-98 without proper ethical approval, failed to conduct the research in accordance with the application submitted to the ethics committee, and failed to treat the children admitted into the study in accordance with the terms of the approval given by the ethics committee. For example, it will be alleged that some of the children did not qualify for the study on the basis of their behavioural symptoms.
It is further alleged that the three practitioners permitted a programme of investigations to be carried out on a number of children as part of the research study, some of which were not clinically indicated when the Ethics Committee had been assured that they were all clinically indicated. These investigations included colonoscopies and lumbar punctures. It is alleged that the performance of these investigations was contrary to the clinical interests of the children.
The research undertaken by the three practitioners was subsequently written up in a paper published in the Lancet in February 1998 entitled “Ileal-Lymphoid-Nodular Hyperplasia, Non-Specific Colitis and Pervasive Developmental Disorder in Children” (“the Lancet paper”).
It is alleged that the three practitioners inaccurately stated in the Lancet paper that the investigations reported in it were approved by the ethics committee.
The Panel will inquire into allegations that Dr Wakefield and Professor Walker-Smith acted dishonestly and irresponsibly in failing to disclose in the Lancet paper the method by which they recruited patients for inclusion in the research which resulted in a misleading description of the patient population in the Lancet paper. It is further alleged that Dr Wakefield gave a dishonest description of the patient population to the Medical Research Council.
The Panel will inquire into allegations that Dr Wakefield and Professor Walker-Smith administered a purportedly therapeutic substance to a child for experimental reasons prior to obtaining information about the safety of the substance. It is alleged that such actions were irresponsible and contrary to the clinical interests of the child.
The Panel will inquire into allegations that Dr Wakefield was involved in advising solicitors acting for persons alleged to have suffered harm by the administration of the MMR vaccine. It is alleged that Dr Wakefield’s conduct in relation to research funds obtained from the Legal Aid Board (“LAB”) was dishonest and misleading. It will be alleged that Dr Wakefield ought to have disclosed his funding from the LAB to the Ethics Committee but did not.
The Panel will inquire into allegations that Dr Wakefield ordered investigations on some children as part of the research carried out at the Royal Free Hospital from 1996-98 without the requisite paediatric qualifications to do so and in contravention of his Honorary Consultant appointment.
The Panel will inquire into allegations that Dr Wakefield failed to disclose his involvement in the MMR litigation, his receipt of funding from the LAB and his involvement in a Patent relating to a new vaccine to the Editor of the Lancet which was contrary to his duties as a senior author of the Lancet paper.
The Panel will inquire into allegations that Dr Wakefield acted unethically and abused his position of trust as a medical practitioner by taking blood from children at a birthday party to use for research purposes without ethics committee approval, in an inappropriate social setting, and whilst offering financial inducement.
We cannot guarantee that all those wishing to attend the hearing will be able to do so, as seating is limited. If you plan to attend the hearing please email the GMC press office press@gmc-uk.org. In the event that we have to allocate seats those people who have notified the press office will be seated before others.
-Ends-For further information please contact the Media Relations Office on 020 7189 5454, out of hours 020 7189 5444, fax 020 7189 5401, email press@gmc-uk.org, website http://www.gmc-uk.org.
The General Medical Council licenses doctors to practise medicine in the UK. Our purpose is summed up in the phrase: Regulating doctors, Ensuring Good Medical Practice.
The law gives us four main functions:
• keeping up-to-date registers of qualified doctors
• fostering good medical practice
• promoting high standards of medical education
• dealing firmly and fairly with doctors whose fitness to practise is in doubt
Left Brain Right Brain 
These are serious allegations. You can’t just go around using children as guinea pigs and thumbing your nose at research ethics. If they’ve crossed a very clear line here, I hope the panel recognizes that. There should be zero encouragement for this kind of sneaky behavior in human “subjects” research. These guidelines and standards exist to prevent researchers from exploiting vulnerable populations. I’d say that the target patients and their families were extraordinarily vulnerable to exploitation and that especial care should have been taken to ensure that all codes and ethical requirements were carefully followed to the very letter and spirit of these rules. It would appear that was not the case…but we’ll see.
Some context might be useful. Here is a link to the text of the Declaration of Helsinki, the internationally-accepted guidelines for medical research:
http://www.wma.net/en/30publications/10policies/b3/index.html
Let’s hope this is like the Autism Omnibus cases in the US, where it became apparent upon the release of the decisions that the reason it took so long for them to come out was that the judges who wrote them were very careful to explain in detail why the vaccine-autism claimants’ arguments could not be true.
Keep in mind that the goal of research is to give us more information. Whether a link is found between vacines and autism or not, the overall goal is to provide us with information to make informed decisions. Research is complicated. If you have ever tried it…there are millions of factors to consider. You can not rule them all out. I think Wakefield is a good man trying to do good things. The children and families who donated their blood samples agreed to do so.
I disagree Kelli, I think he’s an opportunist who was caught.
Remember, there are several charges which relate to appropriation of funds, representation of role, and representation of methodology in response to concerns.
To say Wakefield is a good man when the relevant authourity that determines non-criminal charges against doctors has found otherwise is an odd position to take.
Kelli, The goal of publishing in the scientific literature is to accurately diseminate knowledge. Wakefield was found to have been dishonest and misleading multiple times in what he published.
Lying about your research does not give anyone more information.